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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It is alleged that an advance 35 lp low profile balloon catheter was being used during a procedure involving a severely calcified lesion in the patient's left sfa when the balloon ruptured.The balloon was advanced via ipsilateral approach from the patient's left cfa following a wire guide.It was during the dilation that the balloon ruptured at 10 atm of pressure, which lies within the nominal, or recommended, pressure provided in the ifu.There was no unintended section of the device remaining inside of the patient.It was unknown as to what direction the balloon ruptured.The device will not be returned as it has been discarded by the customer.It is not known what type of contrast or mix of contrast to saline was used to inflate the balloon.The procedure was completed successfully with the another manufacturer's device.No adverse event have been reported regarding this instance.
Additional Manufacturer Narrative
Corrected information: report source: foreign, user facility, company representative.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications, quality control, and inspection of the unused product from the same lot was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.An unused, sealed advance 35lp low profile balloon catheter was evaluated from lot 5611922.The device measured within specifications.No non-conformities were noted.Catheter was smooth, clean and not damaged.Balloon had no surface defects.Balloon burst at 23atm.A document-based investigation was performed.The device history record for lot 5611922 was reviewed and noted one nonconforming event that may contribute to this failure mode.There was one other reported complaints for this lot number, not related to the same failure mode.Per the physician, "i think this rupture occurred because the target lesion was a severely calcified one." the ifu states, ""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." based upon the information provided, the characteristics displayed and no returned product.The root cause was determined to be related to human anatomy.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: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6745551
• Report Number: 1820334-2017-02037
• Device Sequence Number: 771642
• Product Code: DQY
• UDI-Device Identifier: 10827002523354
• UDI-Public: (01)10827002523354(17)180128(10)5611922
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2017

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: PTA5-35-80-4-12.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1