MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event is currently under investigation.
Event or Problem Description
It was report that during an angioplasty the radiologist inflated the balloon to 5 atm and the balloon burst, possibly circumferentially (mdr # 1820334-2016-00838).When the radiologist tried to remove the balloon catheter it seemed stuck and then a piece broke off the end, remaining inside the patient.A larger sheath and snare were used to capture the piece of balloon that was in the patient anatomy (mdr # 1820334-2016-00820).A section of the device did not remain inside the patient's body.The alleged incident reportedly prolonged the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Mdr # 1820334-2016-00820 was determined to be a duplicate of mdr # 1820334-2016-00838.
Event or Problem Description
It was report that during an angioplasty the radiologist inflated the balloon to 5 atm and the balloon burst, possibly circumferentially ( mdr # 1820334-2016-00838).When the radiologist tried to remove the balloon catheter it seemed stuck and then a piece broke off the end, remaining inside the patient.A larger sheath and snare were used to capture the piece of balloon that was in the patient anatomy (mdr # 1820334-2016-00820).A section of the device did not remain inside the patient¿s body.The alleged incident reportedly prolonged the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ADVANCE 35 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: 5900608
• Report Number: 1820334-2016-00820
• Device Sequence Number: 18933559
• Product Code: LIT
• UDI-Device Identifier: 10827002343747
• UDI-Public: (01)10827002343747(17)190219(10)6747935
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2016

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: PTA5-35-80-12-2.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Supplement Report FDA Received Date: 03/16/2017
• 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