MAUDE Adverse Event Report: BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE; SIMILAR DEVICE D134801, PMA # P030031/S078

Catalog Number D139505

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi then conducted visual inspection of the returned device.Visual inspection was performed, in accordance with bwi procedures.Visual inspection found a hole at the pebax with reddish material inside of it.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instruction for use contains the following warnings and precautions: do not use excessive force to advance or withdraw the catheter when resistance is encountered during catheter manipulation through the sheath.The qdot-micro, bi-directional, d-f curve, c3, split handle catheter reported in this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to stsf: thermocool smarttouch® sf catheters approved under (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

A patient underwent an atrial fibrillation (afib) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle for which biosense webster¿s product analysis lab identified external damage (a hole) on the pebax of the device during returned product analysis.It was initially reported by the customer that during the afib procedure, after mapping and before ablation, the physician notice that a foreign material, described as ¿blood¿ accumulated in the pebax tube.The catheter was replaced with a new one to successfully complete the procedure.The issue delayed the procedure 3 minutes.There was no patience consequence.The issue of blood accumulation inside the pebax area is not considered to be mdr reportable since it was found underneath the pebax.However, there is no damage to the pebax integrity that could cause the foreign material to travel into the blood circulation.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 7-jul-2021, the bwi product analysis lab (pal) received the complaint device for evaluation.On 3-sep-2021, pal revealed that a visual inspection found a ¿hole¿ at the pebax and a reddish material inside it.This finding was reviewed and determined to be mdr reportable since the integrity of the device was compromised.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through visual analysis on 3-sep-2021 and reassessed it as mdr reportable.

• Brand Name: QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE
• Type of Device: SIMILAR DEVICE D134801, PMA # P030031/S078
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12550729
• MDR Text Key: 274020168
• Report Number: 2029046-2021-01637
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2021
• Device Catalogue Number: D139505
• Device Lot Number: 30398632L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1