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

Model Number	N/A
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that during an unspecified procedure on the superficial femoral artery (side unspecified), the advance 35 lp low profile balloon catheter balloon would not inflate to nominal pressure and it was losing dye.The patient's anatomy was not tortuous or calcified, and there was no angulation.The balloon was injected with 50/50 contrast/ saline, and there was no difficulty crossing anything while advancing.The device was removed and another of the same was used to complete the procedure with no harm to the patient.The reporter postulated that the leak could not have been due to a rupture because the balloon never inflated to nominal pressure.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
Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used 35 lp advance balloon catheter was returned for evaluation and examination.A pin hole is noted at the proximal end of the balloon bond.No damage was noted to the catheter shaft.Review of the device history record of the finished product shows there were two non-conformances related to failed test leakage and relevant to the device failure.Based on the information provided, there were no other reported complaints for this lot number.The device length measured within specifications.Based on the information provided, examination of the returned product, 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.

• 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: 6919503
• Report Number: 1820334-2017-03524
• Device Sequence Number: 852925
• Product Code: LIT
• UDI-Device Identifier: 10827002355320
• UDI-Public: (01)10827002355320(17)200224(10)7704106
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K132020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: N/A
• Device Catalogue Number: PTA5-35-135-5-20.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1