MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G30830

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 09/03/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, during a superficial femoral and tibial atherectomy procedure with stent placement, involving a patient is his seventies, an advance 18 lp low profile pta balloon dilatation catheter separated.Access was obtained in the tibial vessel via the ankle.The vessels were reportedly extremely calcified.A cook 6 x 20 balloon was used first; however that device ruptured circumferentially.The ruptured 6 x 20 balloon will be reported under patient identifier (b)(6).The complaint device was then inserted via groin access to prevent bleeding.The balloon reportedly became mangled and separated.The user attempted to remove the separated portion with a snare, but was unsuccessful.The separated portion of the device was then stented in place.Reportedly, the tibial artery was tied off.The physician speculated that calcification was a contributing factor.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.Additional information has been requested, but is unavailable at this time.

Manufacturer Narrative

Additional information: this report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

Event Description

Additional information was received.The device did not rupture, but rather folded over itself and separated as the wire guide was removed.The tibial artery was ligated, using a stitch, during the procedure.In addition to being extremely calcified, the anatomy was also slightly angulated, with a three-degree angle reported.The lesion was located within the proximal superficial femoral artery.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a superficial femoral and tibial atherectomy procedure with stent placement, involving a patient is his seventies, an advance 18 lp low profile pta balloon dilatation catheter separated.Access was obtained in the tibial vessel via the ankle.The vessels were reportedly extremely calcified.A cook 6 x 20 balloon was used first; however that device ruptured circumferentially.The ruptured 6 x 20 balloon will be reported under patient identifier 308406.The complaint device was then inserted via groin access to prevent bleeding.The balloon reportedly folded over itself and separated as the wire guide was removed.The tibial artery was ligated, using a stitch, during the procedure.In addition to being extremely calcified, the anatomy was also slightly angulated, with a three-degree angle reported.The lesion was located within the proximal superficial femoral artery.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complainant returned one used balloon catheter to cook for investigation.Biomatter was present on the returned device.Physical examination of the returned device showed the balloon was separated and only 1 cm of balloon remained on the catheter shaft.No marker bands were present on the returned device.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 for both otw and px ¿the balloons are manufactured from an extra-thinwall, high-strength, minimally compliant material.Particular care should be taken in handling the balloons to prevent damage.They will inflate to the indicated size parameters when utilizing proper pressure recommendations.Adhere to balloon inflation pressure parameters indicated in the compliance card insert.Refer to label for further information.Use of a pressure gauge is recommended to monitor inflation pressures.¿ intended use ¿the advance 18lp low profile pta balloon dilatation catheter has been designed for percutaneous transluminal angioplasty (pta) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral, and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.¿ instructions for use balloon preparation ¿choose a balloon appropriate to lesion length and vessel diameter.¿ ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ balloon introduction and inflation ¿note: if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution.¿ ¿inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.(see compliance card insert.)¿ ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ balloon deflation and withdrawal ¿upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.¿ how supplied ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that the patient¿s anatomy most likely contributed to this incident.As reported, the patient's vessels were reported to be extremely calcified with slight angulation.Additionally, the physician speculated that calcification was a contributing factor to this incident.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 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10529259
• MDR Text Key: 207198662
• Report Number: 1820334-2020-01681
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002308302
• UDI-Public: (01)10827002308302(17)221122(10)10168107
• Combination Product (y/n): N
• PMA/PMN Number: K130293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2020

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: 11/22/2022
• Device Model Number: G30830
• Device Catalogue Number: PTAX4-18-170-3-15
• Device Lot Number: 10168107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 09/15/2020; 12/02/2020
• Supplement Dates FDA Received: 09/17/2020; 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PTA4-18-150-6-20
• Patient Outcome(s): Required Intervention