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

Model Number	24682
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered.The 100% stenosed target lesion was located in the non-tortuous and severely calcified supeficial femoral artery (sfa).Physician crossed retrograde from the posterior tibial artery and gained access from the contralateral groin.The physician was able to floss the guidewire through the 6f sheath out the groin access.A 4.0 x150, 135cm charger balloon catheter was advanced; however, it was noticed that advancing was extremely difficult.The physician performed multiple inflations up and down the length of sfa.A lot of resistance was felt when the physician tried to remove the balloon.The balloon stopped moving back and the catheter stretched and snapped approximately 5 cm from the proximal hub.The physician used a 6f non-bsc guide catheter and advanced it over the balloon catheter to try to capture the balloon in the guide catheter.He was able to advance the guide catheter to the proximal balloon ro marker, but unable to advance the guide catheter over the balloon.He manipulated the guide catheter and the charger balloon catheter together pulling in short stokes to remove the portion of the remaining charger balloon intact.When the half of the balloon was out of the patient's body, the physician cut off a piece of the balloon outside the patient in order to be able to access and manipulate the non-bsc guidewire he had access with.The fractured portion was removed intact from the patient's body.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that removal difficulties were encountered.The 100% stenosed target lesion was located in the non-tortuous and severely calcified superficial femoral artery (sfa).Physician crossed retrograde from the posterior tibial artery and gained access from the contralateral groin.The physician was able to floss the guidewire through the 6f sheath out the groin access.A 4.0 x150, 135cm charger balloon catheter was advanced; however, it was noticed that advancing was extremely difficult.The physician performed multiple inflations up and down the length of sfa.A lot of resistance was felt when the physician tried to remove the balloon.The balloon stopped moving back and the catheter stretched and snapped approximately 5 cm from the proximal hub.The physician used a 6f non-bsc guide catheter and advanced it over the balloon catheter to try to capture the balloon in the guide catheter.He was able to advance the guide catheter to the proximal balloon ro marker, but unable to advance the guide catheter over the balloon.He manipulated the guide catheter and the charger balloon catheter together pulling in short stokes to remove the portion of the remaining charger balloon intact.When the half of the balloon was out of the patient's body, the physician cut off a piece of the balloon outside the patient in order to be able to access and manipulate the non-bsc guidewire he had access with.The fractured portion was removed intact from the patient's body.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the charger 4.0x150, 135cm was received for analysis.The device was received in three sections due to two complete shaft breaks.The distal section of the device was received advanced through the customer's 6fr sheath.For investigation purposes, the sheath was dissected to facilitate an examination of the balloon material of the device.As per charger specification, the recommended sheath for this device is minimum 5fr.The device was returned inside the customer's 6fr sheath.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning approximately 60mm distal of the proximal markerband and extending for approximately 5mm distally.An examination of the balloon material and markerbands identified no other issues with the balloon material.As per charger specification, the rated burst pressure is 20 atmospheres.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be detached at two locations.The first break was located approximately 40mm distal of the strain relief.The second break was located approximately 200mm distal of the first break.The shaft was also noted to be severely stretched/damaged and accordioned at more than one location.This type of damage is consistent with resistance being encountered and excessive tensile force being applied to the device during withdrawal through the sheath.A microscopic examination found no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on 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: 12304691
• Report Number: 2134265-2021-09896
• Device Sequence Number: 3612107
• Product Code: LIT
• UDI-Device Identifier: 08714729804048
• UDI-Public: 08714729804048
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2021

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: 02/11/2023
• Device Model Number: 24682
• Device Catalogue Number: 24682
• Device Lot Number: 0025200696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Initial Date Received by Manufacturer: 07/26/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/20/2021
• 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: 59 YR