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

Model Number	G52381
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter occupation = tech.Device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a procedure involving placement of a venous stent, an advance 35 lp low profile balloon catheter stuck inside another manufacturer's 7 french sheath after it was inflated.The balloon and sheath were reportedly removed together over an unknown wire.The vessels were not angulated or calcified.The procedure was successfully completed by introducing a new sheath and balloon over the original wire.Upon return and initial evaluation of the device, the distal portion of the balloon catheter was found to be separated.A section of the device did not remain inside the patient¿s body.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 Manufacturer Narrative
Description of event: as reported, during a procedure involving placement of a venous stent, an advance 35 lp low profile balloon catheter stuck inside another manufacturer's 7 french sheath after it was inflated.The balloon and sheath were reportedly removed together over an unknown wire.The vessels were not angulated or calcified.The procedure was successfully completed by introducing a new sheath and balloon over the original wire.Upon return and initial evaluation of the device, the distal portion of the balloon catheter was found to be separated.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, drawings, the instructions for use, and quality control data.One pta5 balloon catheter was returned to cook for investigation.Examination of the device showed bio-matter present and the distal end of the catheter separated at 17.9cm.A competitor¿s sheath was also returned, the catheter was not lodged in the sheath when received.Both marker bands are present.The catheter was stretched at the separation point for a length of 4.4cm.There was a kink noted just below the strain relief.The balloon does not appear damaged.A leak test could not be performed due to the catheter separation.A review of the device history record found one non-conformance related to the reported failure mode.Although the nonconformance is relevant to the reported failure mode, all non-conforming product were scrapped, there are 100% inspections to capture this non-conformance.A database search showed there were 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.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: instructions for use balloon deflation and withdrawal 2.Deflate the balloon by pulling vacuum on the inflation syringe or inflation device.Maintain vacuum on the balloon and withdraw the catheter.Upon catheter withdrawal, a gentle counterclockwise rotation of the catheter will assist balloon rewrap, minimizing trauma to the percutaneous entry site.3.If resistance is met during withdrawal, apply negative pressure with a larger syringe before proceeding.If resistance continues, remove balloon and sheath as a unit.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.Cook concluded that user error contributed to the reported failure mode.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 or Problem Description
No new patient or event information to report.

• 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
• MDR Report Key: 11903187
• Report Number: 1820334-2021-01425
• Device Sequence Number: 1403086
• Product Code: DQY
• UDI-Device Identifier: 10827002523811
• UDI-Public: (01)10827002523811(17)231006(10)13471865
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 10/06/2023
• Device Model Number: G52381
• Device Catalogue Number: PTA5-35-80-12-10.0
• Device Lot Number: 13471865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO PINNACLE 7FR SHEATH