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

Model Number	8575
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgery was required to remove the catheter.The 99% stenosed target lesion was located in the distal right coronary artery (rca).The femoral artery seemed to be tortuous just past the sheath insertion.A 6f runway al1 sh guide catheter was selected for use.After the catheter was inserted, three kinks were observed on it.The physician tried to straighten the kinks with a 0.38 wire while part of the catheter remained inside the patient.The catheter broke at the proximal section.The portion of the device inside the patient was unable to be retrieved.The patient was sent to theatre to have the al1 guide removed.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer; returned product consisted of an incomplete runway guide catheter.The device was bloody.Analysis of the shaft and hub included microscopic and visual inspection.Inspection revealed only 17.6 cm of the shaft was returned, with a kink 33 mm from the strain relief.The distal end of the broken edge was frayed and twisted.Inspection of rest of the device did not find any other damage or defect.The reported kink and broken device was confirmed, however; the reported device jamming could not be confirmed as clinical circumstances could not be replicated.
Event or Problem Description
It was reported that the surgery was required to remove the catheter.The 99% stenosed target lesion was located in the distal right coronary artery (rca).The femoral artery seemed to be tortuous just past the sheath insertion.A 6f runway al1 sh guide catheter was selected for use.After the catheter was inserted, three kinks were observed on it.The physician tried to straighten the kinks with a 0.38 wire while part of the catheter remained inside the patient.The catheter broke at the proximal section.The portion of the device inside the patient was unable to be retrieved.The patient was sent to theatre to have the al1 guide removed.No patient complications were reported and the patient's status was stable.

• Brand Name: RUNWAY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10364244
• Report Number: 2134265-2020-10380
• Device Sequence Number: 14214040
• Product Code: DQY
• UDI-Device Identifier: 08714729478836
• UDI-Public: 08714729478836
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K033441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2022
• Device Model Number: 8575
• Device Catalogue Number: 8575
• Device Lot Number: 0060186195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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: 84 YR