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

Model Number	G52293
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that during an iliac stenting procedure, an advance 35 lp low profile balloon catheter ruptured.The device was used to post-dilate an unknown manufacturer's stent.Access was obtained in the right common femoral artery (cfa) and an ipsilateral approach was used to reach the calcified lesion with an unspecified 6 french cook performer sheath and unknown manufacturer's 0.035 wire guide.Both angulation and vessel calcification were noted during the procedure.The complaint device was inflated inside the stent to 4 atmospheres (atm) with 50/50 saline and isoview contrast mixture when it ruptured "circumfrentially".The complaint device did not come into contact with the stent struts at the time of rupture.The physician was unable to remove the device through the 6fr sheath, and therefore pulled the catheter with enough force to elongate the device and dissect the inner catheter.It was reported that approximately 90% of the balloon catheter was removed with this technique.The 0.035 wire guide was replaced with an unknown 0.018 wire guide and the 6fr sheath replaced with an unknown 8fr sheath and dilator.The balloon was unable to be removed through this device, as well.The physician then replaced the 8fr sheath with an unknown 11fr device and the complaint device was removed successfully.The procedure was completed successfully with another cook balloon.A section of the device did not remain inside the patient¿s body.T he 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 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, unavailable, or unchanged.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufactures instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one advance 35 lp low profile balloon catheter was returned for investigation.The returned device was in two separate portions and covered in biomatter.The distal most portion of the shaft, which contained part of the balloon material was found to be stretched and elongated.The distal marker band freely moved on this portion of the device.The proximal most piece contained the other part of the balloon material, with the unsecured marker band beneath the balloon material.The point of separation of the balloon material was noted to be circumferential.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed one nonconforming event which could potentially contribute to this failure mode.This nonconformance was for a cut shaft and it was found and scraped during the manufacturing process.It should also be noted there were no other reported complaints for this lot number.Furthermore, a review of the manufactures instructions, drawing, and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be traced to our device.Investigation has concluded that the patient condition was the most likely cause of this event as the vessel was reported to have calcification and angulation.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.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.

• 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: 8245395
• Report Number: 1820334-2019-00066
• Device Sequence Number: 19448721
• Product Code: DQY
• UDI-Device Identifier: 10827002522937
• UDI-Public: (01)10827002522937(17)210828(10)9124174
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (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): 03/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: G52293
• Device Catalogue Number: PTA5-35-135-10-4.0
• Device Lot Number: 9124174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention