MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER; CATHETER, PERCUTANEOUS

Model Number 26102

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Hematoma (1884); Tissue Damage (2104); Perforation of Vessels (2135); No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2019

Event Type  Injury  

Manufacturer Narrative

Event date was not provided.(b)(6) 2019 was used as the event date as the aware date was 11 mar 2019.Device is combination product.

Event Description

It was reported that a balloon could not be deflated.The 7mm x 40mm, 135 cm ranger dcb balloon was used but could not be deflated.

Manufacturer Narrative

Date of event: correction.Event: updated.

Event Description

It was reported that a balloon could not be deflated.An intervention was being performed on a 75% stenotic left femoral artery.The 7mm x 40mm, 135 cm ranger dcb balloon was inflated with an encore 26 inflator and a platinium guidewire.Once the lesion was treated, the balloon could not be deflated.The balloon was forcibly removed from the patient.The patient did not experience any major complications with the exception of a hematoma at the puncture site and possibly some damage to the humeral artery.

Event Description

It was reported that a balloon could not be deflated.An intervention was being performed on a 75% stenotic left femoral artery.The 7mm x 40mm, 135 cm ranger dcb balloon was inflated with an encore 26 inflator and a platinium guidewire.Once the lesion was treated, the balloon could not be deflated.The balloon was forcibly removed from the patient.The patient did not experience any major complications with the exception of a hematoma at the puncture site and possibly some damage to the humeral artery.

Manufacturer Narrative

Device evaluated by mfr: the tip, balloon, proximal bond and inner/outer shafts were microscopically and visually inspected.The device was received with contrast inside the balloon and inflation lumen (outer shaft), with the balloon loosely folded.Inspection revealed a complete separation in the shaft located 99.4cm from the tip of the device, with the entire distal shaft (separated end of the device) was damaged (stretched/flattened), and numerous kinks in the shaft.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Functional testing could not be done, due to the shaft of the device being completely separated.The reported deflation difficulty and removal difficulty could not be confirmed, as the clinical circumstances could not be replicated.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8470881
• MDR Text Key: 140535934
• Report Number: 2134265-2019-03236
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2020
• Device Model Number: 26102
• Device Catalogue Number: 26102
• Device Lot Number: 7530H18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Date Manufacturer Received: 05/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1