MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number	24630
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 30's.
Event or Problem Description
It was reported that the balloon broke apart and was snared.A 8.00mm/90cm 2cm peripheral cutting balloon was used during a venogram procedure.During procedure, the balloon was inflated, and then as it was deflated, the physician tried to exchange it over the wire.It was then noted that the whole balloon broke apart from the catheter.The balloon was then snared out and a bigger sheath was used to retrieve the broken device.All parts of the balloon was retrieved and nothing was left inside the patient's body.The procedure was completed using an extra large balloon.No patient complications were reported and patient's status was fine.
Event or Problem Description
It was reported that the balloon broke apart and was snared.A 8.00mm/90cm 2cm peripheral cutting balloon was used during a venogram procedure.During procedure, the balloon was inflated, and then as it was deflated, the physician tried to exchange it over the wire.It was then noted that the whole balloon broke apart from the catheter.The balloon was then snared out and a bigger sheath was used to retrieve the broken device.All parts of the balloon was retrieved and nothing was left inside the patient's body.The procedure was completed using an extra large balloon.No patient complications were reported and patient's status was fine.Device eval by manufacturer:the balloon was unfolded which indicated it had been subjected to positive pressure and blood was noted within the balloon material which is evidence of a device leak.The midpoint of the balloon material was also noted to be severely kinked.Due to the condition of the device the balloon material could not be inflated.A visual and microscopic examination was performed the returned device and a small circumferential tear approximately 2mm in length was identified in the balloon material approximately 10mm distal to the distal edge of the proximal balloon bond within the severe kink in the balloon material.The kinking and bunching on the balloon material is consistent with the balloon material being compressed which most likely occurred during removal with the snare.A visual and tactile examination found severe kinking and stretching damage along the length of the catheter.A completed break was also identified in the shaft of the device at the proximal balloon bond.This shaft damage is consistent with excessive force being applied to the delivery system during withdrawal of the device.A visual and microscopic examination identified no damage or any issues with the tip, markerbands or blades of the device that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon material.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Age at time of event: (b)(6).
Event or Problem Description
It was further reported that resistance was encountered while attempting to remove the balloon out of the body after inflation.It was reported that the balloon broke apart and was snared.A 8.00mm/90cm 2cm peripheral cutting balloon was used during a venogram procedure.During procedure, the balloon was inflated, and then as it was deflated, the physician tried to exchange it over the wire.It was then noted that the whole balloon broke apart from the catheter.The balloon was then snared out and a bigger sheath was used to retrieve the broken device.All parts of the balloon was retrieved and nothing was left inside the patient's body.The procedure was completed using an extra large balloon.No patient complications were reported and patient's status was fine.Device eval by manufacturer:the balloon was unfolded which indicated it had been subjected to positive pressure and blood was noted within the balloon material which is evidence of a device leak.The midpoint of the balloon material was also noted to be severely kinked.Due to the condition of the device the balloon material could not be inflated.A visual and microscopic examination was performed the returned device and a small circumferential tear approximately 2mm in length was identified in the balloon material approximately 10mm distal to the distal edge of the proximal balloon bond within the severe kink in the balloon material.The kinking and bunching on the balloon material is consistent with the balloon material being compressed which most likely occurred during removal with the snare.A visual and tactile examination found severe kinking and stretching damage along the length of the catheter.A completed break was also identified in the shaft of the device at the proximal balloon bond.This shaft damage is consistent with excessive force being applied to the delivery system during withdrawal of the device.A visual and microscopic examination identified no damage or any issues with the tip, markerbands or blades of the device that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon material.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Age at time of event: (b)(6).

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7793881
• Report Number: 2134265-2018-60220
• Device Sequence Number: 13776340
• Product Code: PNO
• UDI-Device Identifier: 08714729813804
• UDI-Public: 08714729813804
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K151253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2020
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0021871467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/17/2018; 10/07/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 10/03/2018; 11/06/2018
• 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