MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24681
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.A 9.0 x60, 75cm charger balloon catheter was advanced for dilation.An encore pi was used as an inflation device.However, during inflation at 22 atmospheres, past the appropriated rated limit, the balloon ruptured and was stuck in the 6fr x 7cm super sheath.They were working over a regular angled.035x180 zipwire.The balloon would not come through the sheath due to the raveling of the proximal tip of the balloon outside the sheath in the fistula.The distal part of the balloon was cut and the sheath was removed with balloon still in the vessel.The balloon was removed using a 8fr and 10fr sheath.The procedure was completed and there were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.A 9.0 x60, 75cm charger balloon catheter was advanced for dilation.An encore pi was used as an inflation device.However, during inflation at 22 atmospheres, past the appropriated rated limit, the balloon ruptured and was stuck in the 6fr x 7cm super sheath.They were working over a regular angled.035x180 zipwire.The balloon would not come through the sheath due to the raveling of the proximal tip of the balloon outside the sheath in the fistula.The distal part of the balloon was cut and the sheath was removed with balloon still in the vessel.The balloon was removed using a 8fr and 10fr sheath.The procedure was completed and there were no patient complications nor injuries reported.It was further reported that the 80% stenosed target lesion was located in the non-tortuous and non-calcified right atrioventricular access.The procedure was completed with a different device.
Event or Problem Description
It was reported that balloon rupture occurred and removal difficulties were encountered.A 9.0 x60, 75cm charger balloon catheter was advanced for dilation.An encore pi was used as an inflation device.However, during inflation at 22 atmospheres, past the appropriated rated limit, the balloon ruptured and was stuck in the 6fr x 7cm super sheath.They were working over a regular angled.035x180 zipwire.The balloon would not come through the sheath due to the raveling of the proximal tip of the balloon outside the sheath in the fistula.The distal part of the balloon was cut and the sheath was removed with balloon still in the vessel.The balloon was removed using a 8fr and 10fr sheath.The procedure was completed and there were no patient complications nor injuries reported.It was further reported that the 80% stenosed target lesion was located in the non-tortuous and non-calcified right atrioventricular access.The procedure was completed with a different device.
Additional Manufacturer Narrative
Device evaluated by mfr.: the charger device 9x60x75cm was received for analysis.The device was received in two sections due to a complete shaft break.The distal section of the device was received inside the customer's intoducer sheath.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 30mm distal of the proximal balloon sleeve.The balloon material was also torn longitudinally beginning at the circumferential tear and extending approximately 30mm distal across the balloon material to the proximal balloon sleeve.The distal section of balloon material had been pushed distally towards the tip of the device.This type of damage most probably occurred when the device was being withdrawn through the sheath.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device as per charger specification is 16 atmosphers.A visual and microscopic examination observed damage to the tip of the device.This type of damage is consistent with the device encountering resistance when attempting to cross the lesion.A visual and tactile examination found the shaft of the device to have completely detached at the distal edge of the strain relief.It was reported that the physician dissected the shaft during the procedure.Severe stretching damage and kinking was also noted begining approximally at the distal markerband and extending to the proximal balloon sleeve.This type of damage is consistent with excessive tensile force being applied to the device.A visual examination and microscopic examination found no damage or issues with the markerbands of the device.No other issues were identified during the product analysis.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10190281
• Report Number: 2134265-2020-08433
• Device Sequence Number: 886215
• Product Code: FGE
• UDI-Device Identifier: 08714729804765
• UDI-Public: 08714729804765
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• 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): 08/03/2020

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: 03/04/2023
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0025302882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 07/27/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/24/2020; 08/03/2020
• 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