MAUDE Adverse Event Report: CATH F6INF TL JL 4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534620T
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation, but the manufacture report is not yet available.A review of the device history record (dhr) associated with lot 17975587 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, the physician noticed that there was blood dripping out of a hole in the 6f 100cm judkins left 4 (jl4) infiniti catheter when he put it through the sheath (unknown).There was no reported patient injury.The device was stored as per labeling and was opened in a sterile field.The device was stored, handled and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.There were no anomalies noted prior to inserting into the patient.There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.The procedure was completed using another device.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the physician noticed that there was blood dripping out of a hole in the 6f 100cm judkins left 4 (jl4) infiniti catheter when he put it through the sheath (unknown).There was no reported patient injury.The device was stored as per labeling and was opened in a sterile field.The device was stored, handled and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.There were no anomalies noted prior to inserting into the patient.There was no damage noticed to the device prior to opening the package.There was no difficulty removing the device from the sterile packaging.The procedure was completed using another device.One non-sterile infiniti diagnostic catheter (cath f6inf tl jl 4 100cm) was received for analysis.During visual inspection, a puncture/hole was noted approximately at 18.1 cm from distal tip.No other anomalies were observed during the analysis.Per functional analysis, a flushing test was performed.A leakage was noted through the puncture/hole found during visual review.Due to the puncture/hole found on the body of the unit, an sem analysis was performed and results showed that the inner surface of the catheter unit presented bulged/peeled off material along the puncture/hole.The outer surface presented evidence of scratch marks and bulged/peeled off material near to the puncture/hole.This type of damage is commonly caused during the interaction of the catheter material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and bulged/peeled off material on the unit¿s outer surface probably led to the punctured condition found on the received unit.It seems the catheter material was punctured with a sharp object from the outside of the unit.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17975587 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿catheter (body/shaft) ¿ leakage¿ was confirmed since a puncture/hole was found, and during functional analysis, a leakage was confirmed through the hole.Sem analysis results showed that the inner surface of the catheter presented marks and bulged/peeled off material near the puncture/hole.The outer surface presented evidence of scratch marks.This type of damage is commonly caused during the interaction of the catheter with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and bulged/peeled off material on the unit¿s outer surface probably led to the punctured condition found on the received unit.It seems the catheter material was punctured with a sharp object from the outside of the unit.Procedural and/or handling factors might have contributed to the observed damages.According to the ifu, which is not intended as a mitigation of risk, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.Exercise care when removing guidewires from multiple-curve catheters.To prevent kinking of 5f (1.65 mm) and smaller angiographic catheters: straighten the pigtail catheter tip only with a diagnostic guidewire or, if applicable, with a tip straightener.Do not straighten by hand.Use a guidewire when introducing the catheter through the catheter sheath introducer (csi) and into the left ventricle.Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.¿ neither the product analysis nor the phr results suggest that the condition found on the unit could be related to the manufacturing process.No corrective action will be taken at this time.

• Brand Name: CATH F6INF TL JL 4 100CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11693700
• Report Number: 9616099-2021-04438
• Device Sequence Number: 3073275
• Product Code: DQO
• UDI-Device Identifier: 10705032014182
• UDI-Public: 10705032014182
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 534620T
• Device Catalogue Number: 534620T
• Device Lot Number: 17975587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK SHEATH
• Patient Age: 71 YR