MAUDE Adverse Event Report: EMBOLX, INC. SNIPER BALLOON OCCLUSION CATHETER; INFUSION CATHETER WITH BALLOON OCCLUSION

Model Number	SBC0629-KTP-150
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Problem attributed to manufacturer error.Assembler at contract manufacturer placed a single unsealed unit with sealed units during the pouch sealing process.Assembler was notified of the error and training for the assembler (at a minimum) has commenced along with a scar (supplier corrective action request) for the contract manufacturer.Contract manufacturer understands the nature and severity of the issue.Remaining inventory for the lot was inspected for this condition along with other similar lots with zero other incidents.
Event or Problem Description
Primary pouch packaging of the device was not sealed.Device was not used on a patient.Device was packaged (one pouch per shelf box), labeled, and sterilized with pouch end open, unsealed.Operator and embolx representative noted compromise to packaging and returned the device unused to embolx.

• Brand Name: SNIPER BALLOON OCCLUSION CATHETER
• Common Device Name: INFUSION CATHETER WITH BALLOON OCCLUSION
• Manufacturer (Section D): EMBOLX, INC.; 530 lakeside dr ste 200; sunnyvale CA 94085
• MDR Report Key: 8938093
• Report Number: 3011660785-2019-00001
• Device Sequence Number: 19370952
• Product Code: MJN
• UDI-Device Identifier: 00853359008087
• UDI-Public: (01)00853359008087(17)200611(10)EMB06111904
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2019

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 Expiration Date: 06/11/2020
• Device Model Number: SBC0629-KTP-150
• Device Catalogue Number: SBC0629-KTP-150
• Device Lot Number: EMB061119-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1