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

Model Number	24634
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon would not deflate and additional intervention was required.The target lesion was located in the left pulmonary artery.A 8.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During procedure, after positioning and inflation, the balloon would not deflate despite the pressure was pulled to negative pressure of 60cc.Consequently, the hub was cut off of balloon catheter and physician went over with a 12f sheath placed against the proximal end of balloon.Finally, the balloon was able to be pulled while inflated into the sheath and all successfully removed from the patient's body.The procedure was completed with a different device.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The balloon was found to contain blood and hardened media.It was placed in water bath in order to soften the media.The device was removed from the bath and was unable to be inflated as the hub had been removed from the device.An inflation was attempted using a syringe attached to an encore inflation device and inserted into the inflation lumen of the device.However, as the shaft of the device was badly damaged, the inflation attempt was unsuccessful.The damaged portion of the shaft was removed and inflation using a syringe and encore inflation device was again attempted and this time the balloon was successfully inflated to rate of burst pressure.The rated burst pressure for this device is 10 atmospheres.The device was then successfully deflated within 20 seconds.No issues noted with the blades of this device.All blades bonded securely to the balloon surface.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination identified multiple damages along the shaft.The shaft hub was also missing from the device and was not returned as part of the complaint.
Event or Problem Description
It was reported that the balloon would not deflate and additional intervention was required.The target lesion was located in the left pulmonary artery.A 8.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During procedure, after positioning and inflation, the balloon would not deflate despite the pressure was pulled to negative pressure of 60cc.Consequently, the hub was cut off of balloon catheter and physician went over with a 12f sheath placed against the proximal end of balloon.Finally, the balloon was able to be pulled while inflated into the sheath and all successfully removed from the patient's body.The procedure was completed with a different device.No further patient complications were reported.

• 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: 10082801
• Report Number: 2134265-2020-06881
• Device Sequence Number: 19545096
• Product Code: PNO
• UDI-Device Identifier: 08714729813781
• UDI-Public: 08714729813781
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 06/22/2020

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: 05/29/2020
• Device Model Number: 24634
• Device Catalogue Number: 24634
• Device Lot Number: 0022184414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 06/22/2020
• 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: 4 YR