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

Model Number G50328

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Occupation: other non-healthcare professional: materials management supervisor.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 a leg case with stenosis a advance 14 lp low profile balloon catheter was removed from the packaging and the tip was found to be frayed.Another device was used to complete the procedure.The device did not make patient contact.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, prior to a leg case with stenosis a advance 14 lp low profile balloon catheter was removed from the packaging and the tip was found to be frayed.Another device was used to complete the procedure.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one prior to use balloon catheter to cook for investigation.Physical examination of the returned device showed that the balloon was returned not wrapped.Inspection found clear strands of hydrophilic coating coming off the balloon surface.The balloon was inflated to 18atm and no leakage found.There was no damage to the balloon catheter tip.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: device description ¿the balloon is manufactured from an extra-thinwall, high-strength, minimally complaint 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 requirements.¿ ¿the balloon surface has a hydrophilic coating which becomes slippery when in contact with fluids.¿ instructions for use balloon preparation ¿upon removal from package, inspect catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation ¿activate the hydrophilic coating by wiping the balloon with heparinized saline solution.¿ how supplied: ¿upon removal package, inspect the product to ensure no damage has occurred.¿ a capa was previously been opened to address hydrophilic coating (hc) fibers found during placement of the balloon protector in the balloons department for ptax4 and pta3 devices.The capa was closed at the root cause investigation phase given the mixed results of the particulate testing.A risk benefit analysis (rba) was completed and concluded that the product benefits outweigh the risks associated with hc fibers.Cook has concluded a definitive conclusion could not be determined.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information to report.

• 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: 10459044
• MDR Text Key: 204729970
• Report Number: 1820334-2020-01569
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503288
• UDI-Public: (01)10827002503288(17)230618(10)13255888
• Combination Product (y/n): N
• PMA/PMN Number: K170193
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: G50328
• Device Catalogue Number: PTAX4-14-170-3-4
• Device Lot Number: 13255888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1