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	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The product will not be returned for evaluation.
Event or Problem Description
It was reported that during an av fistula angioplasty procedure using an advance 35 lp low profile balloon catheter, the balloon fragmented in the right cephalic vein during the last inflation.It was reported that the inflation pressure was above the nominal pressure rate.Contrast used was a 50/50 mix ultravist 370.There was no angulation or vessel calcification noted.The balloon was noted to have burst circumferentially.The largest fragment was retrieved however, a smaller piece that included the radiopac segment migrated into the collateral vein of the right arm but did not pose a hemodynamic problem.An attempt was made to retrieve the piece without success.It was reported that the patient is asymptomatic and the fistula (dialysis) is working without any complication.
Additional Manufacturer Narrative
A review of the complaint history, 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 examinations could be performed; however, a document-based investigation was performed.There is no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.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.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this is a manufacturing issue.Based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was technique related or human anatomy related.However, 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 warranted.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: 6461367
• Report Number: 1820334-2017-00529
• Device Sequence Number: 591315
• Product Code: DQY
• UDI-Device Identifier: 10827002523743
• UDI-Public: (01)10827002523743(17)191020(10)7373860
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-10-6.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 07/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 85