MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-170-2-12
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.Each device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.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 was one other reported complaints for this lot number relevant to the device failure mode.Based on the information provided, no product returned, 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.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
It was reported that during an endoscopic third ventriculostomy (etv), the advance 14 lp low profile balloon catheter was inserted from the right groin and advanced to the anterior tibial artery (ata).The balloon catheter ruptured at 6 atm, before reaching nominal pressure.The direction (circumferentially or longitudinally) of the balloon rupture was reported as unknown.Another manufacturer's device was utilized to complete the procedure.The patient had critical limb ischemia (cli) prior to the procedure; no calcification was present in the patient's anatomy.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ADVANCE 14 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: 7032536
• Report Number: 1820334-2017-03898
• Device Sequence Number: 13805627
• Product Code: DQY
• UDI-Device Identifier: 10827002503172
• UDI-Public: (01)10827002503172(17)171218(10)5527996
• Combination Product (Y/N): N
• PMA/510(K) Number: K090822
• 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
• Report Date (Section B): 11/15/2017

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: PTAX4-14-170-2-12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1