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

Model Number	24681
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); No Code Available (3191)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced tachycardia and hypertension.The target lesion was located in the superficial femoral artery (sfa).A 4.0x100, 135cm charger balloon catheter was crossed the lesion and dilation was performed in two inflations to nominal.However, when the device was removed, the patient became tachycardic and hypotensive.The patient was put on pressures, medication and get the blood pressure up and stable.The procedure was stopped after ballooning due to the patient's reaction.No further patient complications were reported.The patient will have surgery to correct the sfa lesion.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device found that the balloon had been inflated and was not refolded.No issues were noted with the balloon material.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No issues were identified during the product analysis.
Event or Problem Description
It was reported that the patient experienced tachycardia and hypertension.The target lesion was located in the superficial femoral artery (sfa).A 4.0x100, 135cm charger balloon catheter was crossed the lesion and dilation was performed in two inflations to nominal.However, when the device was removed, the patient became tachycardic and hypotensive.The patient was put on pressures, medication and get the blood pressure up and stable.The procedure was stopped after ballooning due to the patient's reaction.No further patient complications were reported.The patient will have surgery to correct the sfa lesion.It was further reported that the target lesion was 100% in-stent stenosis, fibrous with plaque which extend distal to the stent located in the distal sfa and proximal popliteal artery.It was around 5 minutes after balloon removal that the patient became hypotensive and tachycardiac.The patient had an allergic reaction to balloon coating.It was believed the patient may or had a reaction to either the contrast or sedation at this time.The patient was premedicated to help prevent another possible reaction.
Event or Problem Description
It was reported that the patient experienced tachycardia and hypertension.The target lesion was located in the superficial femoral artery (sfa).A 4.0x100, 135cm charger balloon catheter was crossed the lesion and dilation was performed in two inflations to nominal.However, when the device was removed, the patient became tachycardic and hypotensive.The patient was put on pressures, medication and get the blood pressure up and stable.The procedure was stopped after ballooning due to the patient's reaction.No further patient complications were reported.The patient will have surgery to correct the sfa lesion.It was further reported that the target lesion was 100% in-stent stenosis, fibrous with plaque which extend distal to the stent located in the distal sfa and proximal popliteal artery.It was around 5 minutes after balloon removal that the patient became hypotensive and tachycardiac.The patient had an allergic reaction to balloon coating.It was believed the patient may or had a reaction to either the contrast or sedation at this time.The patient was premedicated to help prevent another possible reaction.
Event or Problem Description
It was reported that the patient experienced tachycardia and hypertension.The target lesion was located in the superficial femoral artery (sfa).A 4.0x100, 135cm charger balloon catheter was crossed the lesion and dilation was performed in two inflations to nominal.However, when the device was removed, the patient became tachycardic and hypotensive.The patient was put on pressures, medication and get the blood pressure up and stable.The procedure was stopped after ballooning due to the patient's reaction.No further patient complications were reported.The patient will have surgery to correct the sfa lesion.It was further reported that the target lesion was 100% in-stent stenosis, fibrous with plaque which extend distal to the stent located in the distal sfa and proximal popliteal artery.It was around 5 minutes after balloon removal that the patient became hypotensive and tachycardiac.The patient had an allergic reaction to balloon coating.It was believed the patient may or had a reaction to either the contrast or sedation at this time.The patient was premedicated to help prevent another possible reaction.

• 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: 9466342
• Report Number: 2134265-2019-15682
• Device Sequence Number: 14186635
• Product Code: FGE
• UDI-Device Identifier: 08714729804017
• UDI-Public: 08714729804017
• 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,Followup
• Report Date (Section B): 03/05/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2022
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0024507033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/02/2020; 01/13/2020; 02/19/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/13/2020; 01/30/2020; 03/05/2020
• 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: 50 YR