MAUDE Adverse Event Report: COOK INC ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	PTA3-14-150-2-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
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
During an angioplasty procedure treating a lesion in the distal anterior tibial artery, the balloon portion of the advance micro ¿ 14 ultra low-profile pta balloon catheter ruptured longitudinally after inflation, at "no more than" 16 atmospheres (atm).The complaint device was removed with some difficulty, reportedly catching on calcified portion of the patient's vasculature.Another balloon catheter was inserted to aid with removal.The complaint device was completely removed, and the procedure was completed successfully.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.
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
Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a pinhole, which was noted to be located a distance of 12.5 cm from the distal end of the device (which is the proximal end of the balloon).The balloon did not burst.Kinks were noted as lengths of 5.8 cm, 11.9 cm, 33.3 cm, 58.7 cm, and 101.4 cm from the proximal end of the device.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 the lot was released meeting all finished goods release criteria.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ADVANCE MICRO ¿ 14 ULTRA LOW-PROFILE PTA BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7686886
• Report Number: 1820334-2018-02033
• Device Sequence Number: 1316288
• Product Code: LIT
• UDI-Device Identifier: 10827002266411
• UDI-Public: (01)10827002266411(17)201006(10)8273186
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K122940
• 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): 10/11/2018

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 Expiration Date: 10/06/2020
• Device Catalogue Number: PTA3-14-150-2-12
• Device Lot Number: 8273186
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1