MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	PTA4-18-150-2-12
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = k130293.(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 of the lower extremity for a popliteal lesion, the advance 18 lp low profile balloon catheter ruptured.The balloon was inflated at nominal pressure, and the patient was reported to have vessel calcification.Two balloon catheters ruptured during the procedure, refer to mdr 1820334-2017-03678 for additional report.The angioplasty was able to be successfully completed with another cook medical balloon catheter.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, drawings, device history record, documentation, instructions for use (ifu), specifications,and quality control was conducted during the investigation.The complaint device was not returned for evaluation.One advance 18 lp low profile balloon catheter representative device from the same lot (8055148) was obtained for investigation.The balloon was returned in the original sealed box and shipping holder.No crows feet appeared to be present.The balloon was able to inflated to 15 atmosphere (atm) without rupturing [rated burst pressure = 14 atm].No surface defects were noted to the balloon.The balloon's length and diameter both measured within specifications.The surface of catheter was smooth, clean and free of damage.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.There is no information regarding the preparation of the device.The patient was reported to have vessel calcification.Per the ifu, "the balloon is manufactured from an extra-thinwall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage.Choose a balloon appropriate to lesion length and vessel diameter." there is no mention of resistance noted during procedure.Per the ifu, "if resistance is met while advancing the balloon dilatation catheter, determine the cause and proceed with caution." based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time; however, it is plausible that this event is related to patient anatomy.Appropriate measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.Personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE 18 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: 6996844
• Report Number: 1820334-2017-03677
• Device Sequence Number: 19084004
• Product Code: LIT
• UDI-Device Identifier: 10827002309378
• UDI-Public: (01)10827002309378(17)200711(10)8055148
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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 Catalogue Number: PTA4-18-150-2-12
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1