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

Model Number	H749394671500
Medical Device Problem Codes	Fluid/Blood Leak (1250); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 28aug2026.It was reported that a fluid leak occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified left coronary artery.A 1.50mm rotapro was selected for use.During the procedure while outside the patient, when performing air removal on the advancer, near the tube where the rota cocktail flows, rota solution was leaking out.The procedure was completed with another of the same device and no patient complications were reported.However, device analysis revealed the sheath was torn at 20.6cm.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes: device analysis findings: the device was returned for analysis.A visual inspection of the device found that at 17.2cm, 17.8cm, 18.2cm, 19.3cm, and 20.3cm distal from the strain relief, the sheath was kinked and worn.At 20.6cm the sheath was torn.Additionally, the sheath was contaminated as blood was present.The coil was stretched from the handshake connection to the burr end of the device.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was considered adverse event related to procedure.It was considered likely that the reported events and the condition of the returned device occurred due to procedural factors which can include device interaction and device testing.

• Brand Name: ROTAPRO?
• Common Device Name: catheter, coronary, atherectomy
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50820255
• Report Number: 2124215-2026-49982
• Device Sequence Number: 15990528
• Product Code: MCX
• UDI-Device Identifier: 08714729999577
• UDI-Public: (01)08714729999577(17)280224(10)38677310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749394671500
• Device Catalogue Number: H749394671500
• Device Lot Number: 0038677310
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown