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	06/26/2017
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 for a procedure when the balloon ruptured.It was reported that the complaint device was advanced to the target lesion in cto over another manufacturer's wire guide by ipsilateral approach.The complainant continues that it was during the pre-dilation of the cto lesion in the iliac artery that the balloon ruptured.Another "35 lp" balloon was used to successfully complete the procedure.No adverse events have been reported regarding 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.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.The customer stated the device was used with a competitor's wire guide.There is no information about the dimensions of the competitor's device or if the competitor's device met their manufacturer's quality specifications.The customer stated there was severe calcification in the lesion.According to 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.There is no information from the customer regarding the method and monitoring of the balloon inflation.The rated burst pressure (rbp) is documented in the compliance card and label that is included with the device as well as the ifu.The ifu states, "adhere to balloon inflation pressure parameters indicated in the compliance card insert.Do not exceed rated burst pressure.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.Based upon the information provided and the characteristics displayed, and no product returned, it is plausible to suggest that this incident was technique related, device compatibility related or human anatomy related.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: 6732033
• Report Number: 1820334-2017-01798
• Device Sequence Number: 1161287
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521(17)180204(10)5629169
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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: PTA5-35-80-7-4.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1