MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50314

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Occupation = manager.Pma/510(k) number = k170193.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, prior to patient contact, saline leaked from an advance 14 lp low profile balloon catheter during preparation of the device.A syringe was used to prepare the balloon with saline when the balloon was found to be leaking.Another device of the same type was used to complete the procedure.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Summary of event: as reported, prior to patient contact, saline leaked from an advance 14 lp low profile balloon catheter during preparation of the device.A syringe was used to prepare the balloon with saline when the balloon was found to be leaking.Another device of the same type was used to complete the procedure.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection and functional test of the complaint device were conducted during the investigation.Visual inspection of the complaint device confirmed the return of one ptax4-14-170-2-4 to cook for investigation.There was biomatter present on the device.The balloon was attempted to be inflated using an inflation device.The leak test showed that the balloon was leaking at the proximal end near the proximal bond.There was a tear on the proximal end of the balloon.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The complaint file, device history record, complaint history, validations, and manufacturing documents provide objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.The product ifu states: ¿the balloon is manufactured from an extra-thinwall, high-strength, minimally compliant material.Particular care should be taken in handling the balloon to prevent damage.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.¿ the ifu also warns: ¿do not exceed rated burst pressure.Rupture of balloon may occur.¿ the ifu instructs: ¿upon removal from package, inspect catheter to ensure no damage has occurred during shipping.The label on the product package indicates that for the ptax4-14-170-2-4, the nominal inflation pressure is 8atm and the rated burst pressure is 16atm.The compliance card insert details balloon inflation pressures stating that for balloons that measure 2mm in width and 4cm in length, the nominal inflation pressure is 8atm and the rated burst pressure is 16atm.A review of the manufacturer¿s instructions and quality control procedures was conducted, and no gaps were discovered.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a definitive cause for the event cannot be determined.The risk analysis for this failure mode was reviewed and no action was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9648053
• MDR Text Key: 177368537
• Report Number: 1820334-2020-00241
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503141
• UDI-Public: (01)10827002503141(17)220905(10)9993067
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2022
• Device Model Number: G50314
• Device Catalogue Number: PTAX4-14-170-2-4
• Device Lot Number: 9993067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1