MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PULMONARY; BRONCHOSCOPE ACCESSORY

Model Number	M00550310
Medical Device Problem Codes	Burst Container or Vessel (1074); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary balloon was used in the inferior vena cava during an angioplasty procedure performed on (b)(6) 2021.During the procedure, the balloon was inflated to 3 atm to predilate the stenosis and was then deflated and removed from the patient.The balloon was positioned and inflated at 6 atm to postdilate the stent; however, after 1 minute it was noticed that the balloon decreased in pressure and a mixture of blood and contrast medium reflow into the insuflator.Additionally, a rupture was noted.The device was removed and the procedure was completed with another cre pulmonary balloon.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that the cre pulmonary is intended to endoscopically dilate strictures of the airway tree; however, the balloon was used to dilate the inferior vena cava for this case.
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable event of balloon burst.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was contaminated and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pulmonary balloon was used in the inferior vena cava during an angioplasty procedure performed on (b)(6) 2021.During the procedure, the balloon was inflated to 3 atm to predilate the stenosis and was then deflated and removed from the patient.The balloon was positioned and inflated at 6 atm to postdilate the stent; however, after 1 minute it was noticed that the balloon decreased in pressure and a mixture of blood and contrast medium reflow into the insuflator.Additionally, a rupture was noted.The device was removed and the procedure was completed with another cre pulmonary balloon.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that the cre pulmonary is intended to endoscopically dilate strictures of the airway tree; however, the balloon was used to dilate the inferior vena cava for this case.

• Brand Name: CRE PULMONARY
• Common Device Name: BRONCHOSCOPE ACCESSORY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12732077
• Report Number: 3005099803-2021-05562
• Device Sequence Number: 19199301
• Product Code: KTI
• UDI-Device Identifier: 08714729456193
• UDI-Public: 08714729456193
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K023337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: 05/13/2024
• Device Model Number: M00550310
• Device Catalogue Number: 5031
• Device Lot Number: 0027314078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• 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: Male
• Patient Race: White