MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G35536
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during an angioplasty, after positioning the advance 35 lp low profile balloon catheter in the patient's lesion, the balloon began to slowly deflate and would not hold pressure as a small hole was present.Blood from the patient's superficial femoral artery was able to enter the balloon through the hole.Following several attempts at reaching the desired pressure, the physician observed a small amount of blood inside of the manometric syringe and proceeded to remove the balloon catheter.The balloon was unable to be completely deflated during removal as the hole inhibited the manometric syringe from controlling the pressure.The perforated balloon catheter and cuff were able to be removed, and the procedure was successfully completed using another balloon catheter.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, and quality control was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.Review of the device history record showed 3 non-conformances; however, all non-conforming product was scrapped prior to completion of the lot.The sub-assembly device history record was also reviewed and no non-conformances were noted.There were no other reported complaints for this lot number.Numerous design verification and validation activities have been performed to ensure that this device meets design requirement, each balloon is 100% inspected and verified prior to release.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.
Additional Manufacturer Narrative
Additional information was received from the customer regarding the reported incident.Twenty-five images in word file which were obtained as a screen capture were provided along with the complaint report, and a photographic examination was performed.The images were noted to be slightly larger than a postage stamp.Even upon magnification, the only determination which could be made was that a diffusely diseased left superficial femoral artery was treated from a right retrograde approach.The angioplasty balloon could not be identified.A calcified plaque that could perforate a balloon cannot be resolved.The density present in the arteries consistent with contrast was also difficult to discern.The very small images which were of limited quality provided no information with which to confirm the complaint of a hole in the angioplasty balloon.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7112985
• Report Number: 1820334-2017-04486
• Device Sequence Number: 900534
• Product Code: LIT
• UDI-Device Identifier: 10827002355368
• UDI-Public: (01)10827002355368(17)190909(10)7259377
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K132020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2018

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 Model Number: G35536
• Device Catalogue Number: PTA5-35-135-6-20.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/05/2018; 06/19/2018
• Initial Report FDA Received Date: 12/13/2017
• Supplement Report FDA Received Date: 01/10/2018; 06/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1