MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTA5-35-135-3-10.0
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: postal code: (b)(6) phone:(b)(6) 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.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 or Problem Description
As reported, during a procedure involving a stenosed superficial femoral artery (sfa), an advance 35 lp low profile balloon catheter¿s balloon leaked.Another manufacturer¿s 6-french sheath was used for access into the left superficial femoral artery, and the same manufacturer¿s 260-centimeter wire was then inserted into the sheath.A cook 6-french sheath was then placed over the other manufacturer¿s wire guide and advanced over the bifurcation to the right distal superficial femoral artery.The complaint device was then inserted over the wire and advanced to the distal end of the sfa, which was ninety percent occluded, but was not tortuous.Another manufacturer¿s pressure pump was used to inflate the balloon three times, once for ten seconds, once for thirty seconds, and once for fifty seconds.The balloon was inflated to eight-to-twelve atmospheres.During inflation, angiography found that contrast leaked from the balloon, which was unable to be filled.The balloon was not inflated within a stent.The balloon catheter was removed, and another manufacturer¿s balloon was used to successfully complete the procedure.A section of the device did not remain inside the patient's body.The patient did not experience any adverse effects or require any additional procedures due to this event.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a procedure involving a stenosed superficial femoral artery (sfa), an advance 35 lp low profile balloon catheter¿s balloon leaked.Another manufacturer¿s 6-french sheath was used for access into the left superficial femoral artery, and the same manufacturer¿s 260-centimeter wire was then inserted into the sheath.A cook 6-french sheath was then placed over the other manufacturer¿s wire guide and advanced over the bifurcation to the right distal superficial femoral artery.The complaint device was then inserted over the wire and advanced to the distal end of the sfa, which was ninety percent occluded, but was not tortuous.Another manufacturer¿s pressure pump was used to inflate the balloon three times, once for ten seconds, once for thirty seconds, and once for fifty seconds.The balloon was inflated to eight-to-twelve atmospheres.During inflation, angiography found that contrast leaked from the balloon, which was unable to be filled.The balloon was not inflated within a stent.The balloon catheter was removed, and another manufacturer¿s balloon was used to successfully complete the procedure.A section of the device did not remain inside the patient's body.The patient did not experience any adverse effects or require any additional procedures due to this event.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.The used complaint device was returned to cook for investigation.Visually, no damage was noted to the balloon.A leak test was performed, and a pinhole was noted at the distal and 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.Cook also reviewed the device instructions for use (ifu).It states, "particular care should be taken in handling the balloon to prevent damage." a review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Based on the information provided and the results of the investigation, cook has concluded that the patient's stenosed anatomy and ninety percent occluded lesion contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation 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 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18974365
• Report Number: 1820334-2024-00417
• Device Sequence Number: 15005904
• Product Code: DQY
• UDI-Device Identifier: 10827002522487
• UDI-Public: (01)10827002522487(17)260802(10)CINC004802
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: 08/02/2026
• Device Catalogue Number: PTA5-35-135-3-10.0
• Device Lot Number: CINC004802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: APT PRESSURE PUMP; APT¿S 260 WIRE GUIDE; APT¿S 6F SHEATH; KCFW-6.0-38-40-RB-BLKN
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 50 KG