MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133602

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Rupture (2208); No Code Available (3191)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30226216m number, and no internal actions related to the complaint was found during the review.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and the catheter tip broke.During the procedure, the catheter tip broke.The catheter was changed to treat the patient.The procedure was prolonged for about 60 minutes.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The procedure delay without effect on the patient¿s condition was assessed as not reportable as there was no risk to the patient.The reported "catheter tip broke" was assessed as a reportable malfunction.

Manufacturer Narrative

Additional information was received on the event and the patient.It was reported that a 59 year old (date of birth (b)(6) 1960) male patient (72kg) underwent a cardiac ablation and suffered mitral valve injury requiring surgical intervention.The procedure was prolonged for about 10 minutes.The patient¿s mitral valve annulus sustained damage and had to be replaced with an artificial valve.Extended hospitalization was required due to the surgical intervention.The physician¿s opinion regarding the causality of the event is that it was due to product malfunction since the catheter insulation was damaged.Medical history was diabetic not insulin dependent, hypertension and cholesterol.H6: patient code of ¿no code available¿ represents ¿surgical intervention." the biosense webster inc.(bwi) product analysis lab received the device for evaluation on november 4, 2019 and it was returned in the condition reported as the catheter integrity was not maintained.The bwi product analysis lab¿s initial inspection performed on november 4, 2019 revealed that the pebax appeared cracked.Reddish material in pebax sleeve.No internal parts exposed.Complaint catheter was further inspected on november 12, 2019 and it was found with a kink on shaft 13.5¿ inches of distance from the handle and a hole on the pebax with reddish-brown material inside.No other damages were observed.Since the device integrity was not maintained, the returned condition remains assessed as a reportable issue.Investigation summary: the device was inspected and the pebax was observed cracked with reddish material inside, no internal parts were observed.During the second visual inspection, the shaft was observed bent and a hole was observed on the pebax area.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force test cannot be performed since the catheter was occluded.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, deflection test was performed and it was found within specifications.Then, an irrigation test was performed and the catheter failed.A failure analysis was performed and the catheter was dissected on the shaft area, the irrigation tubing was found bent, no other damages were observed on the irrigation tube.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding the tip broke could be related to the damage on the pebax.Therefore, the customer complaint was confirmed.In other hand, the root cause of the event adverse remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the damage on the pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.The root cause of body shaft kink could be related to the handling of the device during the shipment; however, this cannot be conclusively determined.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Additional information and clarification was received on the event on 9/12/2019.During the procedure, the catheter got stuck in the ventricle.The physician had a high resistance when he removed the catheter.Then it was noticed that the tip became partially separated.It is not clear whether there were exposed components.The customer also reported force issues before the entrapment.The catheter was changed to treat the patient.The procedure was prolonged for about 60 minutes.In physician¿s opinion the delay did not contribute to serious injury to the patient.The patient¿s mitral valve annulus sustained damage.The physicians opinion regarding the causality of the event and the patient¿s condition is unknown.Initially, it was reported that the catheter tip broke and it was assessed as a reportable issue.Clarification was received stating that it was a partially detached tip.This issue remains a reportable issue as the catheter integrity was not maintained.The adverse event of the mitral valve annulus sustained damage was also assessed as a reportable event.The device entrapment was assessed as a reportable issue.The high force reading was assessed as not reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.Therefore, h1.Type of reportable event was updated to ¿serious injury¿, b1.Is adverse event was checked, b2.Is other serious was checked, h6.Patient codes added ¿rupture¿ and h6.Device codes added ¿entrapment of device or device component¿.In addition, a concomitant product was provided; therefore, processed the d11.Concomitant medical products and therapy dates field.Manufacturer¿s reference number:(b)(4).

Manufacturer Narrative

Additional investigation was performed and was completed on (b)(6) 2020 adding that the device was inspected and no sharp edges were observed.The coil and wires were not protruding the pebax.The coil was not broken.A glove was used and no resistance was observed.Therefore, updated investigation summary: it was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter.During the procedure, the catheter tip broke.The catheter was changed to treat the patient.The procedure was prolonged for about 60 minutes.There was no patient consequence reported.Additional information and clarification was received on the event on (b)(6) 2019.During the procedure, the catheter got stuck in the ventricle.The physician had a high resistance when he removed the catheter.Then it was noticed that the tip became partially separated.It is not clear whether there were exposed components.The customer also reported force issues before the entrapment.The catheter was changed to treat the patient.The patient¿s mitral valve annulus sustained damage.Additional information was received on the event and the patient.It was reported that a 59 year old (date of birth (b)(6) 1960) male patient (72kg) underwent a cardiac ablation and suffered mitral valve injury requiring surgical intervention.The procedure was prolonged for about 10 minutes.The patient¿s mitral valve annulus sustained damage and had to be replaced with an artificial valve.Extended hospitalization was required due to the surgical intervention.The device was inspected and the pebax was observed cracked with reddish material inside, no internal parts were observed.During the second visual inspection, the shaft was observed bent and a hole was observed on the pebax area.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force test cannot be performed since the catheter was occluded.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, deflection test was performed and it was found within specifications.Then, an irrigation test was performed and the catheter failed.A failure analysis was performed and the catheter was dissected on the shaft area, the irrigation tubing was found bent, no other damages were observed on the irrigation tube.The device was inspected and no sharp edges were observed.The coil and wires were not protruding the pebax.The coil was not broken and a glove was used and no resistance was observed.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding the tip broke could be related to the damage on the pebax, therefore, the customer complaint was confirmed.In other hand, the root cause of the event adverse remains unknown.The ifu states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the damage on pebax cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The root cause of body shaft kink could be related to the handling of the device during the shipment, however, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9009914
• MDR Text Key: 157878630
• Report Number: 2029046-2019-03626
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2020
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30226216M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 09/12/2019; 11/04/2019; 03/20/2020
• Supplement Dates FDA Received: 10/02/2019; 11/19/2019; 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ST. JUDE SHEATH
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 72