MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Peripheral ROTAPRO?; catheter, peripheral, atherectomy

Model Number	H749395141500
Medical Device Problem Codes	Entrapment of Device (1212); Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event: literature article publication date.E1: initial reporter address 1: (b)(6).Detailed product information was not provided to bsc, because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.Bagheri a, mojahedi a, rosario bp, rosario pg, geskin g.Novel technique for resolving a stuck rotational atherectomy device in a peripheral artery: a case report.Am j cardiovasc dis.2025 oct 15;15(5):324-329.Doi: 10.62347/kcjb9557.Pmid: 41278604; pmcid: pmc12629882.
Event or Problem Description
It was reported that via literature article that device entrapment occurred requiring intervention.A patient presented for endovascular intervention.Ultrasound guided access was initially obtained in the right common femoral artery (cfa) for the primary intervention.Following device entrapment, additional retrograde access was obtained via the right posterior tibial artery (pta) to facilitate device retrieval.Co2 angiography revealed total occlusion in the proximal to mid superficial femoral artery (sfa) and popliteal artery, with single vessel runoff via the peroneal artery.Pta was occluded in the midportion, and the anterior tibial artery was occluded proximally with distal reconstitution.The lesions in the sfa and popliteal artery were crossed with difficulty using a non-bsc wire and a non-bsc catheter.A rotawire (boston scientific bsc) was placed in the distal pta and rotational atherectomy was performed using a 1.5 mm rotablator (boston scientific bsc) burr.During atherectomy of pta, the burr became lodged in the distal segment and could not be retrieved using standard methods.A novel retrieval technique was employed to resolve this complication.Under ultrasound guidance, retrograde access was obtained via the right pta.The occluded pta was then retrogradely crossed, with the wire advanced into the popliteal artery.Sequential balloon angioplasty was performed around the entrapped burr using balloons measuring 1.5 x 40 mm, 2.0 x 40, and 2.5 x 40 mm.Following this pre dilation, the rotator device was successfully retrieved without any residual complications.After retrieving the device, definitive treatment was performed.Post dilation of the sfa and popliteal artery was accomplished using a 6 x 200 mm balloon.Stenting was completed with a 7 x 80 mm biomimetic stent in the popliteal artery and an 8 x 40 mm stent in the sfa.Final angiography showed improved flow with 40% residual stenosis in both lesions.The patient tolerated the procedure well and experienced no complications.Post-procedural angiography demonstrated excellent flow through the pta and peroneal arteries.The right cfa access site was closed with a celt device, and manual pressure was applied to the pta access site.

• Brand Name: Peripheral ROTAPRO?
• Common Device Name: catheter, peripheral, atherectomy
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Cork Limited; model farm road; cork ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25459237
• Report Number: 2124215-2026-30932
• Device Sequence Number: 8726147
• Product Code: MCW
• UDI-Device Identifier: 00191506007126
• UDI-Public: (01)00191506007126
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K220962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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 Model Number: H749395141500
• Device Catalogue Number: H749395141500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 08/24/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male