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

Model Number 24690

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

It was reported that shaft perforation occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified right superficial femoral artery (sfa).A long regional chronic total occlusion from the right sfa bifurcation to p1 was treated with both ipsilateral forward and retrograde ipsilateral and back of knee approaches.A 6fr non-boston scientific (bsc) guiding sheath was placed from the ipsilateral prograde and a 3fr sheath was placed from the back of the knee.Advanced through the occlusion with a non-bsc microcatheter and a jupiterfc3 guidewire from the ipsilateral forward side.Crossing became difficult in the calcified area, so worked with a jupitert15 guidewire from the back of the knee, but was unable to rendezvous with the micro on the forward side, so continued up the retrograde system to the sfa bifurcation.The site of passage of the retrograde system was confirmed by intravascular ultrasound (ivus) from the antegrade side and confirmed to be the lumen of the vessel.The retrograde system was placed in the forward sheath to construct a pull-through and replaced with a 300 cm support wire before dilation and stenting.The lesion was well dilated and the blood flow was good.Subsequently, an appropriate preparation was made to stop the bleeding at the knee puncture site.A 4.0mmx60mmx135cm (4f) sterling balloon catheter was advanced.However, when the guidewire was tried to cross through the rear end of the wire, the rear end of the wire penetrated the inner shaft of the balloon and went through to the outside of the balloon.Since dilation could not be performed as it was, a 4-100 mustang was used to stop the bleeding and complete the procedure.No patient complications were reported.

Manufacturer Narrative

Age at time of event: (b)(6) or older.Initial reporter city: (b)(6).

Event Description

It was reported that shaft perforation occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified right superficial femoral artery (sfa).A long regional chronic total occlusion from the right sfa bifurcation to p1 was treated with both ipsilateral forward and retrograde ipsilateral and back of knee approaches.A 6fr non-boston scientific (bsc) guiding sheath was placed from the ipsilateral prograde and a 3fr sheath was placed from the back of the knee.Advanced through the occlusion with a non-bsc microcatheter and a jupiterfc3 guidewire from the ipsilateral forward side.Crossing became difficult in the calcified area, so worked with a jupitert15 guidewire from the back of the knee, but was unable to rendezvous with the micro on the forward side, so continued up the retrograde system to the sfa bifurcation.The site of passage of the retrograde system was confirmed by intravascular ultrasound (ivus) from the antegrade side and confirmed to be the lumen of the vessel.The retrograde system was placed in the forward sheath to construct a pull-through and replaced with a 300 cm support wire before dilation and stenting.The lesion was well dilated and the blood flow was good.Subsequently, an appropriate preparation was made to stop the bleeding at the knee puncture site.A 4.0mmx60mmx135cm (4f) sterling balloon catheter was advanced.However, when the guidewire was tried to cross through the rear end of the wire, the rear end of the wire penetrated the inner shaft of the balloon and went through to the outside of the balloon.Since dilation could not be performed as it was, a 4-100 mustang was used to stop the bleeding and complete the procedure.No patient complications were reported.

Manufacturer Narrative

(a2) age at time of event: 18 years or older.(e1) initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Microscopic inspection showed a kink 57.6 cm from the hub.A pinhole in the balloon was confirmed 8 mm from the distal tip, a hole in the catheter was confirmed 7mm from the distal tip.Device analysis determined the condition of the returned device was consistent with the reported information of a hole.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14226628
• MDR Text Key: 290372301
• Report Number: 2134265-2022-04210
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729757016
• UDI-Public: 08714729757016
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0028323684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (JUPITER FC3); GUIDEWIRE (JUPITER FC3); INTRODUCER SHEATH (PARENT SELECT / 6F); INTRODUCER SHEATH (PARENT SELECT / 6F); MICROCATHETER (ARMET); MICROCATHETER (ARMET); STENT (ELUVIA / 6-120); STENT (ELUVIA / 6-120)
• Patient Sex: Male
• Patient Race: Asian